A. Technical Field of the Invention
The present invention relates to a device and a process for detecting an analyte in a biological fluid. That device comprises a cover portion with a restricted area for sample application, a separation matrix for separation of the analyte from substances in the sample that interfere with detection of the analyte, means for detecting the analyte and a base portion having a window or opening for measuring the analyte. A process comprises applying a sample of fluid to such a device and detecting a signal generated from an interaction between the analyte and the detection means in the device.
B. Description of the Background Art
There is a need in the analyte detection art for devices and methods that allow for the rapid, accurate determination of biological fluid analyte composition in very small sample sizes. The need for a device using small sample volumes is particularly relevant to the detection of blood analyte composition because of the difficulty and inconvenience of obtaining blood samples from subjects.
Currently available such devices include ACCUCHEK EASY TEST STRIPS.TM. and ACCUTREND.RTM. (Boehringer Mannheim Corp.). Those devices are multilayer reagent systems characterized by non-restricted application-site sizes.
The present invention provides a detection device having a limited application area compared to an underlying separation matrix, which serves to reduce the volume of fluid and time needed for analyte detection. In addition, the separation matrix and underlying detection means are maintained under a required compression state of 14 to 43 percent, based on an uncompressed relaxed state. Preferably, the compression is between 20 and 35 percent that of a relaxed (uncompressed) state.